HIGH-ENERGY ANTI-TACHYCARDIA THERAPY
Embodiments of the invention are related to medical devices and methods for delivery high-energy anti-tachycardia therapy to a subject, amongst other things. In an embodiment, the invention includes a medical device including a controller module configured to administer a plurality of electrical pulses to a patient in response to a detected tachycardia, the electrical pulses comprising an amplitude of greater than 3 Volts and less than 40 Volts, the controller configured to modulate the amplitude of the electrical pulses. In an embodiment, the invention includes a method of treating a tachyarrhythmia including administering a first series of electrical pulses to a patient with an implantable medical device, the electrical pulses including an amplitude of greater than 8 Volts and less than 40 Volts, the first series of electrical pulses having an interval of less than about 600 ms in between individual pulses. Other embodiments are also included herein.
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This application claims the benefit of U.S. Provisional Application No. 61/043,263, filed Apr. 8, 2008, the content of which is herein incorporated by reference.
TECHNICAL FIELDThis disclosure relates generally to medical devices and methods for delivery of therapy to a subject, and more particularly, to medical devices and methods for delivery of high-energy anti-tachycardia therapy to a subject, amongst other things.
BACKGROUND OF THE INVENTIONTachycardia is a heart condition defined in an adult as a heart rate faster than 100 beats/minute. Tachycardia can broadly be classified as either sinus tachycardia, supraventricular tachycardia, or ventricular tachycardia. Sinus tachycardia is generally caused by exercise or emotional stress and is generally normal. Supraventricular tachycardia is defined as a tachycardia that originates above the bifurcation of the bundle of His. Ventricular tachycardia is defined as a tachycardia that originates below the bifurcation of the bundle of His. Some tachycardias are normal while others can have serious consequences including dramatically reducing cardiac output leading to chest pain, syncope, and death. As such, it is important to treat tachycardia appropriately.
Implantable medical devices are commonly used to treat patients with various conditions of the heart including tachycardias. In some cases, an implantable device is used to deliver a high-energy defibrillation or cardioversion shock to a patient's heart. Such shocks are generally successful at terminating tachycardias. However, defibrillation and cardioversion shocks cause extreme discomfort for patients.
Anti-tachycardia pacing (ATP) was developed as another implantable device-based technique for terminating tachyarrhythmias. ATP generally includes the delivery of a series of low-voltage pulses at a very rapid rate. These low-voltage pulses are generally delivered at the same voltage as regular pacing pulses used for treatment of bradycardia. Typically the initial interval between ATP pacing pulses is 80% of the R-R interval of the tachyarrhythmia to be treated. As such, the ATP pacing pulses are delivered at a rate that is faster than the tachyarrhythmia rate. ATP is effective in terminating some types of tachyarrhythmias. However, a need remains for additional techniques of terminating tachyarrhythmias.
SUMMARY OF THE INVENTIONEmbodiments of the invention are related to medical devices and methods for delivery of high-energy anti-tachycardia therapy to a subject, amongst other things. In an embodiment, the invention includes a medical device including a controller module configured to administer a plurality of electrical pulses to a patient in response to a detected tachycardia, the electrical pulses comprising an amplitude of greater than 3 Volts and less than 40 Volts, the controller configured to modulate the amplitude of the electrical pulses.
In an embodiment, the invention includes a method of treating a tachyarrhythmia including administering a first series of electrical pulses to a patient with an implantable medical device, the electrical pulses including an amplitude of greater than 8 Volts and less than 40 Volts, the first series of electrical pulses having an interval of less than about 600 ms in between individual pulses.
In an embodiment, the invention includes a method of treating a patient including monitoring the patient for indicators of tachyarrhythmia; administering a first series of electrical pulses at a voltage less than or equal to 8 Volts; assessing whether or not the tachyarrhythmia has been terminated; and administering a second series of electrical pulses at a voltage greater than 8 Volts if the tachyarrhythmia has not been terminated.
In an embodiment, the invention includes a medical device including a controller module configured to administer a series of electrical pulses to a patient, the electrical pulses including an amplitude of greater than 8 Volts and less than 40 Volts, the first series of electrical pulses having an interval of less than about 600 ms in between individual pulses.
This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense. The scope of the present invention is defined by the appended claims and their legal equivalents.
The invention may be more completely understood in connection with the following drawings, in which:
While the invention is susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail. It should be understood, however, that the invention is not limited to the particular embodiments described. On the contrary, the intention is to cover modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
DETAILED DESCRIPTION OF THE INVENTIONVarious embodiments of the invention can include the delivery of rapid electrical pulses at a relatively high amplitude. The amplitude of the electrical pulses can be high relative to the amplitude of normal pacing pulses, but significantly low relative to defibrillation or cardioversion shocks and thus painless. It is believed that by increasing the amplitude of the pulses, it is possible to increase the effective size of the tissue being stimulated, thereby increasing the likelihood that the tissue associated with the reentrant circuit will be captured leading to more effective termination of tachyarrhythmias. In addition, it is believed that pacing at amplitudes greater than that at which traditional anti-tachycardia pacing is delivered can have positive ionotropic effects, and thus can beneficially increase in cardiac output. In multiple embodiments herein, the amplitude of pulses can be modulated or varied with respect to the programmed amplitude for regular pacing pulses in a cardiac rhythm management device. Various aspects of exemplary embodiments will now be described in greater detail.
Referring now to
Each individual pulse, e.g., 112, is characterized by an amplitude, as is depicted in
In addition, each individual pulse occurs at a particular point in time. The time at which a pulse occurs can be characterized by a time interval 130 between individual pulses. As shown in the embodiment of
At least some of the individual pulses can be non-excitatory based on the timing of their delivery and/or their polarity. For example, in some embodiments, some or all of the pulses can be timed to be delivered during the refractory period.
In some embodiments, the amplitude of each individual pulse is constant within a particular series, but the amplitude of the individual pulses varies from one series to another. For example, in the embodiment depicted in
In another embodiment, the amplitude of each individual pulse varies within a series. For example, in the embodiment depicted in
In yet another embodiment, the time interval from one individual pulse to the next individual pulse within a series may vary. For example,
Each individual pulse can be characterized by a waveform that defines the voltage of the pulse as a function of time. An example waveform of an individual pulse is depicted in
Another embodiment of an individual pulse 700 is depicted in
Various methods may be configured to utilize high energy antitachycardia pulses. These various processes may, for instance, be embodied in the control module of an implantable medical device such as an implantable cardioverter defibrillator (ICD). A first example process 800 is depicted in
At step 804, if a tachyarrhythmia is not detected, then the process returns to step 802 to continue to monitor for the presence of a tachyarrhythmia. However, if a tachyarrhythmia is detected at step 804, then the process proceeds to step 806, wherein low energy antitachycardia pacing is administered to the patient according to techniques known to those of skill in the art. At step 808, it is determined whether the tachyarrhythmia has terminated. If it has, then the process returns to step 802 to continue to monitor for a tachyarrhythmia. However, if the tachyarrhythmia has not terminated, then at step 810 high energy antitachycardia pacing is administered. This process thereby administers high energy antitachycardia pacing only if the tachyarrhythmia does not respond to low energy antitachycardia pacing. This thereby avoids unnecessarily delivering high energy antitachycardia pacing to a patient who is responsive to low energy antitachycardia pacing.
A flow chart of another exemplary process 900 for utilizing high energy antitachycardia pacing is shown in
In some cases, tachyarrhythmias may be hemodynamically unstable and it may be desirable that a process incorporate an appropriate response to an unstable tachyarrhythmia. Hemodynamically unstable tachyarrhythmias are generally more serious because by definition they are characterized by substantially reduced cardiac output. Hemodynamically unstable tachyarrhythmias can include both atrial tachyarrhythmias and ventricular tachyarrhythmias, though ventricular tachyarrhythmias are more likely to be unstable than atrial tachyarrhythmias. Process 1000 depicted in
Hemodynamic stability of a tachyarrhythmia can be assessed in various ways. For example, blood flow through the coronary venous system can be measured and if it falls below a threshold value, then the tachyarrhythmia can be deemed to be hemodynamically unstable. Another technique that can be used involves measuring pressure within the vasculature such as within the right ventricle, the pulmonary artery, the left atrium, the coronary vein, etc. In some embodiments, hemodynamic stability can be assessed using stroke impedance signals (intracardiac, cardiac component of transthoracic impedance, etc). Further techniques can include measuring blood oxygen saturation, coronary venous blood temperature, minute ventilation (MV), and assessing heart sounds.
If the tachyarrhythmia is hemodynamically unstable, then process 1000 proceeds to step 1006 and begins charging defibrillation capacitors, followed by step 1008 where high energy antitachycardia pacing is administered. At step 1010 it is determined whether the tachyarrhythmia is terminated, and if so, then the process returns to step 1002 to continue to monitor for a tachyarrhythmia. However, if the tachyarrhythmia is determined to not be terminated at step 1010, then process 1000 proceeds to step 1012 where a defibrillation shock is administered to the patient. Furthermore, step 1012 may include alerting a health care provider. Referring back to step 1005, if the tachyarrhythmia is not unstable, then process 1000 proceeds to step 1014 to administer low energy antitachycardia pacing. At step 1016 it is determined whether the tachyarrhythmia is terminated, and if so, the process 1000 returns to step 1002 to continue to monitor for tachyarrhythmia. However, if the tachyarrhythmia is not terminated, at step 1018 high energy antitachycardia pacing is administered to the patient. In some embodiments, step 1018 may be followed by step 1020 where a health care provider is alerted. Alerting a health care provider may involve transmitting a signal that is configured to be received by a health care provider, where the signal provides an indication of the medical condition of the patient.
It will be appreciated that various types of tachyarrhythmias can be treated in accordance with embodiments herein. For example, in some embodiments ventricular tachycardia can be treated. In some embodiments, supraventricular tachycardia can be treated. The high-energy anti-tachycardia therapy can be delivered to the tissue site most appropriate based on the type of tachyarrhythmia being treated. By way of example, in some embodiments, the high-energy anti-tachycardia therapy can be delivered to tissue of the right ventricle, the left ventricle, the right atrium, and/or the left atrium.
In some embodiments high energy antitachycardia therapy can be delivered to the tissue of a patient's heart at multiple sites simultaneously. For example, high energy antitachycardia therapy can be delivered to both the right atrium and the right ventricle simultaneously. As another example, high energy antitachycardia therapy can be delivered to both the right ventricle and the left ventricle simultaneously. In embodiments where such therapy is delivered to multiple sites simultaneously, the parameters of the therapy (e.g., timing, amplitude, etc.) can either be the same or can be different. For example, in some cases the amplitude of the therapy administered to the left ventricle can be higher than the amplitude of the therapy administered to the right ventricle.
In some cases, the system can classify the tachyarrhythmia as ventricular tachycardia or another type of tachyarrhythmia and then provide treatment accordingly. In general, ventricular tachyarrhythmias are more serious than non-ventricular tachyarrhythmias. Process 1050 depicted in
If the tachyarrhythmia is ventricular, then process 1050 proceeds to step 1056 and begins charging defibrillation capacitors, followed by step 1058 where high energy antitachycardia pacing is administered. At step 1060 it is determined whether the tachyarrhythmia is terminated, and if so, then the process returns to step 1052 to continue to monitor for a tachyarrhythmia. However, if the tachyarrhythmia is determined to not be terminated at step 1060, then process 1050 proceeds to step 1062 where a defibrillation shock is administered to the patient. Furthermore, step 1062 may include alerting a health care provider. Referring back to step 1055, if the tachyarrhythmia is not ventricular, then process 1050 proceeds to step 1064 to administer low energy antitachycardia pacing. At step 1066 it is determined whether the tachyarrhythmia is terminated, and if so, the process 1050 returns to step 1052 to continue to monitor for tachyarrhythmia. However, if the tachyarrhythmia is not terminated, at step 1068 high energy antitachycardia pacing is administered to the patient. In some embodiments, step 1068 may be followed by step 1070 where a health care provider is alerted.
Some embodiments may utilize a tachyarrhythmia detection strategy that allows for a determination of whether the tachyarrhythmia has an origin close to a particular pacing site. For example, where a plurality of leads are placed within a patient's cardiac tissue (such as with electrodes in the right atrium, right ventricle, and/or coronary vein or left ventricle), it may be possible to determine the origin of the tachyarrhythmia based on the time at which the signal arrives at each lead. This time difference may be used to determine the relative location of the origin of the tachyarrhythmia. For example, if an electrical signal indicative of tachycardia arrives at an electrode within the right ventricle first, then it can be determined that the origin of the tachycardia is closest to that electrode.
A process 1100 can be configured to utilize this determination of the origin, as depicted in
In some embodiments, it is desirable to utilize a patient's prior medical history to determine an appropriate response to a determination that a tachyarrhythmia exists. For example, process 1200 depicted in
Referring now to
The controller module 1372 can include ventricular sensing and pacing channels including sensing amplifier 1352, output circuit 1354, and a ventricular channel interface 1350 which communicates bidirectionally with a port of microprocessor 1348. It will be appreciated that in some embodiments some of the elements of the controller module 1372 shown in
The ventricular sensing and pacing channel can be in communication with stimulation lead 1330 and electrode 1334. The controller module 1372 can include atrial sensing and pacing channels including sensing amplifier 1358, output circuit 1360, and an atrial channel interface 1356 which communicates bidirectionally with a port of microprocessor 1348. The atrial sensing and pacing channel can be in communication with stimulation lead 1328 and electrode 1332. For each channel, the same lead and electrode can be used for both sensing and pacing. The channel interfaces 1350 and 1356 can include analog-to-digital converters for digitizing sensing signal inputs from the sensing amplifiers and registers which can be written to by the microprocessor in order to output pulses, change the pacing pulse amplitude, and adjust the gain and threshold values for the sensing amplifiers. A shock pulse generator 1374 can also be interfaced to the microprocessor for delivering defibrillation shocks to the heart via a separate pair of electrodes 1376, 1378. In some embodiments, electrodes 1376 and 1378 can be disposed along stimulation lead 1330 and stimulation lead 1328 respectively.
It should be noted that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the content clearly dictates otherwise. It should also be noted that the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It should also be noted that, as used in this specification and the appended claims, the phrase “configured” describes a system, apparatus, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase “configured” can be used interchangeably with other similar phrases such as “arranged”, “arranged and configured”, “constructed and arranged”, “constructed”, “manufactured and arranged”, and the like.
One of ordinary skill in the art will understand that the modules, circuitry, and methods shown and described herein with regard to various embodiments of the invention can be implemented using software, hardware, and combinations of software and hardware. As such, the illustrated and/or described modules and circuitry are intended to encompass software implementations, hardware implementations, and software and hardware implementations.
All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains. All publications and patent applications are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.
This application is intended to cover adaptations or variations of the present subject matter. It is to be understood that the above description is intended to be illustrative, and not restrictive. The scope of the present subject matter should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Claims
1. A medical device comprising;
- a controller module configured to administer a plurality of electrical pulses to a patient in response to a detected tachycardia, the electrical pulses comprising an amplitude of greater than 3 Volts and less than 40 Volts, the controller configured to modulate the amplitude of the electrical pulses.
2. The medical device of claim 1, the plurality of electrical pulses comprising a first series of electrical pulses and a second series of electrical pulses, wherein the controller is configured to modulate the amplitude of the electrical pulses between the first series and the second series.
3. The medical device of claim 2, the controller configured to modulate the time interval between the end of the first series and the start of the second series.
4. The medical device of claim 1, the plurality of electrical pulses comprising a first series of electrical pulses and a second series of electrical pulses, wherein the controller is configured to modulate the time interval between individual pulses within the first series.
5. The medical device of claim 1, the controller module further configured to administer a defibrillation shock if the plurality of electrical pulses fail to terminate the tachycardia.
6. The medical device of claim 1, the controller module further configured to classify the tachycardia as either sinus tachycardia, supraventricular tachycardia, or ventricular tachycardia based on sensed myocardial electrical activity, wherein the plurality of electrical pulses are only administered if the tachycardia is classified as either supraventricular tachycardia or ventricular tachycardia.
7. The medical device of claim 1, wherein modulating the amplitude of the electrical pulses comprises increasing the amplitude.
8. The medical device of claim 1, the electrical pulses comprising an amplitude of greater than 8 Volts.
9. A method of treating a tachyarrhythmia comprising:
- administering a first series of electrical pulses to a patient with an implantable medical device, the electrical pulses comprising an amplitude of greater than 8 Volts and less than 40 Volts, the first series of electrical pulses having an interval of less than about 600 ms in between individual pulses.
10. The method of claim 9, the first series comprising between three and eight electrical pulses.
11. The method of claim 9, further comprising assessing intrinsic cardiac electrical activity in between each electrical pulse in the first series.
12. The method of claim 9, further comprising modulating the amplitude of the electrical pulses of the first series.
13. The method of claim 9, wherein the electrical pulses of the first series increase in amplitude between the first electrical pulse of the first series and the last electrical pulse of the first series.
14. The method of claim 9, further comprising administering a second series of electrical pulses.
15. The method of claim 14, wherein the amplitude of the first electrical pulse in the second series is greater than the amplitude of the first electrical pulse in the first series.
16. The method of claim 14, further comprising modulating the timing of a first electrical pulse of the second series.
17. The method of claim 9, wherein each electrical pulse is biphasic.
18. A method of treating a patient comprising:
- monitoring the patient for indicators of tachyarrhythmia;
- administering a first series of electrical pulses at a voltage less than or equal to 8 Volts;
- assessing whether or not the tachyarrhythmia has been terminated; and
- administering a second series of electrical pulses at a voltage greater than 8 Volts if the tachyarrhythmia has not been terminated.
19. The method of claim 18, the indicators of tachyarrhythmia comprising an electrogram signal indicating an R-R frequency of greater than 100 beats per minute.
20. The method of claim 18, further comprising assessing cardiac hemodynamics if indicators of tachyarrhythmia are detected.
Type: Application
Filed: Apr 6, 2009
Publication Date: Oct 8, 2009
Patent Grant number: 8412325
Applicant: CARDIAC PACEMAKERS, INC. (St. Paul, MN)
Inventors: Allan Charles Shuros (St. Paul, MN), Shantha Arcot-Krishnamurthy (Vadnais Heights, MN), Dan Li (Shoreview, MN)
Application Number: 12/419,074
International Classification: A61N 1/39 (20060101); A61N 1/365 (20060101);